Pain Self-management Program for Older Adults
19. November 2019 aktualisiert von: University of Regina
A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery
It is well documented that severe pain is more common in older adults than it is younger persons.
Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management.
Access to effective self-management approaches is particularly important for older adults who may have mobility limitations or live in remote areas, or have difficulty accessing health care services.
The development of effective pain self-management programs for older adults who cannot access traditional psychological interventions is of significant importance.
Internet self-management programs have the potential to address pain undermanagement.
As technology advances, the digital divide between the older and younger demographic continues to progress.
Given the known difficulties with treatment access, the purpose of this study is to explore the efficacy and acceptability of a remotely-delivered chronic pain self-management program tailored to older adults, the Pain Course, when delivered in online and workbook formats.
The program was previously shown to be effective among younger persons but has not been tested with older adults.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The program is delivered through a secure platform administered by the Online Therapy Unit for Service Education and Research at the University of Regina. Using a patient preference randomized control trial (RCT) design, participants (n = 120) will be enrolled in either the online group or workbook group, or to a wait list control group. The content of both programs will be identical and contain 5 core lessons, which participants will be encouraged to work through over an 8-week period. By exploring the efficacy of an online vs. workbook group, the results from this study may serve as a stepping-stone for improved self-management of chronic pain in older adults.
A patient preference randomized controlled trial (RCT) was chosen for this study. The goal is to have most participants accept randomization by emphasizing they are equally acceptable, so only those with a very strong preference or no access to Internet aren't randomized. According to the preliminary power analysis, a total of 120 participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
121
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4S 0A2
- University of Regina
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- are residents of Canada
- are 65 years of age or older
- report experiencing pain for more than three months
- are not experiencing very severe symptoms of depression or anxiety
- have regular access to a computer and the internet
- are proficient in writing and speaking the English language
Exclusion Criteria:
- high suicide risk
- concerns about online therapy
- not present in the country during treatment
- are younger than 65 years of age
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months.
Participants randomized to the Online Group will receive access to the course on the computer (online).
A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy.
The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes.
|
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
|
|
Experimental: Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months.
Participants randomized to the Workbook Group will receive access to the course in a printed (workbook) format.
A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy.
The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes.
|
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
|
|
Kein Eingriff: Wait List Control Group
Participants who are randomly allocated to the wait list control group will be provided access to the course after the twelve-week period has passed.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the impact of pain in several areas of life
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Pain Disability Index (PDI)
|
baseline, 8 weeks, 3 months
|
|
Change in depression
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Geriatric Depression Scale-30 (GDS-30)
|
baseline, 8 weeks, 3 months
|
|
Change in anxiety
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
|
baseline, 8 weeks, 3 months
|
|
Change in chronic pain severity
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Brief Pain Inventory (BPI)
|
baseline, 8 weeks, 3 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Pain Self-Efficacy Questionnaire (PSEQ)
|
baseline, 8 weeks, 3 months
|
|
Change in fear of movement or re-injury
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by TAMPA Scale of Kinesiophobia (TSK)
|
baseline, 8 weeks, 3 months
|
|
Change in acceptance of chronic pain
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)
|
baseline, 8 weeks, 3 months
|
|
Change in tendency to amplify the threat value of constant pain
Zeitfenster: baseline, 8 weeks, 3 months
|
Measured by Pain Catastrophizing Scale (PCS)
|
baseline, 8 weeks, 3 months
|
|
Treatment satisfaction
Zeitfenster: 8 weeks
|
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
|
8 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Thomas Hadjistavropoulos, University of Regina
- Hauptermittler: Heather Hadjistavropoulos, University of Regina
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. Februar 2018
Primärer Abschluss (Tatsächlich)
20. April 2019
Studienabschluss (Tatsächlich)
20. April 2019
Studienanmeldedaten
Zuerst eingereicht
18. April 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. April 2018
Zuerst gepostet (Tatsächlich)
30. April 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. November 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. November 2019
Zuletzt verifiziert
1. November 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2018-004
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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